FDA [to 20 January 2018]
January 16, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
Today the U.S. Government Accountability Office (GAO) published a report titled “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs.” In preparing the report, GAO studied a number of issues related to the FDA’s review and approval of “nonbiological complex drugs.” The report contained a single recommendation for the FDA — that the agency publicly announce its plans to issue or revise guidance for these drug products. We agree with GAO’s recommendation and the FDA is actively working to accomplish this goal through new policies that are already underway…

January 16, 2018 –
FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
Scientific progress and new drug innovation don’t take place in a vacuum. The exchange of information that informs decisions to undertake research, invest in new scientific endeavors, and prescribe and use certain treatments effectively are a critical part of enabling the development and dissemination of new medical technology. Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations.
As part of our efforts to enhance transparency around our drug approval decisions, we’re exploring new ways the U.S. Food and Drug Administration can continue to build on its obligation to share information about product approvals. We’re especially focused on information that can improve patient care and better inform providers about the products they prescribe. One place where we are evaluating how we can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs).
Right now, when a drug is approved, the FDA releases certain information that the agency used when reviewing the new drug application (NDA). This includes summaries written by our medical reviewers that capture their assessment of the data, the proposed labeling or other requirements, and other important, relevant data supporting safe and effective use. This information is included in our drug approvals database, Drugs@FDA…

What’s New for Biologics
Updated: 1/19/2018
SOPP 8795: Posting and Announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials- pdf (PDF – 56KB)

Posted: 1/19/2018
Statistical Review – Fluarix Quadrivalent (PDF – 242KB)

Posted: 1/19/2018 \
Clinical Review – Fluarix Quadrivalent (PDF – 1.2MB)

Posted: 1/17/2018
January 11, 2018 Summary Basis for Regulatory Action – Fluarix Quadrivalent (PDF – 339KB)

Fondation Merieux  [to 20 January 2018]
18 January 2018
The “Forum Espace Humanitaire”: 100 Leaders Discuss Perspectives for Humanitarian Action
Nearly 100 humanitarian leaders and experts will meet at Les Pensières Center for Global Health January 18-20 for the “Forum Espace Humanitaire” (FEH). This forum brings together leaders to address the issues, methods and future evolution of humanitarian action. FEH is organized every 18 months by the Mérieux Foundation in partnership with the French Red Cross and Fondation de France.
PATH  [to 20 January 2018]
Press release | January 16, 2018
Tata Trusts and PATH announce India’s first Impact Lab for Public Health
New Delhi, January 16, 2018—Tata Trusts and PATH today announced the establishment of the Tata Trusts-PATH Impact Lab, the first such in India, to support and bring to market innovations for affordable public health solutions to benefit vulnerable populations with limited resources. Among the priorities will be solutions in maternal and child health, nutrition, and diagnostics for chronic and infectious diseases…

UNAIDS [to 20 January 2018]
19 January 2018
A 30-year response to HIV in Morocco
Morocco marks 30 years of its response to HIV in 2018, with much to celebrate. Concerted efforts in the country have resulted in a 42% reduction in new HIV infections since 2010, significantly greater than the decline across the Middle East and North Africa of just 4%. HIV treatment coverage has also increased in the country, from 16% in 2010 to 48% in 2016.

18 January 2018
Harnessing human rights for the AIDS response
A special section on HIV and human rights has been published in the Health and Human Rights Journal. Eleven papers—covering issues such as HIV-related stigma and discrimination, gender inequality and the effects of the abuse and criminalization of key populations—offer critical reflections on the AIDS response and call for renewed efforts to confront legal, social and structural barriers in order to realize better health for all… The special section is accessible at

17 January 2018
UNAIDS is saddened by the death of Mathilde Krim
UNAIDS is deeply saddened by the death of the prominent AIDS researcher and activist Mathilde Krim. Ms Krim was a pioneer in AIDS research from the earliest days of the AIDS epidemic and a dedicated defender of human rights and justice.
Ms Krim was a research scientist, dedicated to increasing awareness around HIV. She was one of the Founding Chairmen of the Foundation for AIDS Research (amfAR), an organization dedicated to AIDS research, HIV prevention, treatment education and the advocacy of sound AIDS-related public policy.
Her activism, dedication and compassion were instrumental in influencing public policy mobilizing funds for AIDS research and protecting the human rights of people living with HIV or affected by HIV.
In 2000, Ms Krim was awarded the Presidential Medal of Freedom, the highest civilian honour in the United States of America.

UNICEF  [to 20 January 2018]
16 January 2018
Half a million Rohingya refugee children at risk in overcrowded camps in Bangladesh with cyclone and monsoon season on horizon
COX’S BAZAR, Bangladesh, 16 January 2018 – The health and safety of more than 520,000 Rohingya children living in overcrowded camps and informal settlements in Bangladesh is likely to be put at even greater risk ahead of upcoming cyclone and monsoon seasons, UNICEF warned today…
“Unsafe water, inadequate sanitation and poor hygiene conditions can lead to cholera outbreaks and to Hepatitis E, a deadly disease for pregnant women and their babies, while standing water pools can attract malaria-carrying mosquitos. Keeping children safe from disease must be an absolute priority,” Beigbeder added.
More than 4,000 suspected cases of diphtheria have been reported among the refugee population, with 32 deaths including at least 24 children. UNICEF and partners have launched a diphtheria vaccination campaign, and are working to provide children and families with access to safe water and sanitation facilities, but overcrowding and the growing risk of extreme weather increases the risk of further outbreaks…

Wellcome Trust  [to 20 January 2018]
Opinion / Published: 18 January 2018
Researchers crack DNA riddle to show how process of mitosis works
Researchers have answered a fundamental question that has perplexed cell biologists for almost 150 years.   
Tom Collins, from Wellcome’s Genetics and Molecular Sciences team, explains why the discovery is so important and how the research team finally found what had evaded them for so long.

News / Published: 17 January 2018
Wellcome’s approach to engaging the public is going to change
Wellcome has a new public engagement strategy. Imran Khan, Head of Public Engagement, explains why we think it’s necessary and what it means for the way we will work

The Wistar Institute   [to 20 January 2018]
Press Releases
The Wistar Institute Awarded More Than $1.4 Million to Create a Malaria Vaccine Through Synthetic DNA-Based Technology
PHILADELPHIA—(Jan. 18, 2018)—The Wistar Institute is pleased to announce it has been awarded a $1,494,972 grant by the Bill & Melinda Gates Foundation to advance a DNA-based vaccine candidate for protection against malarial infection utilizing a synthetic DNA platform created in the lab of David B. Weiner, Ph.D., executive vice president, director of the Vaccine & Immunotherapy Center at The Wistar Institute and the W.W. Smith Charitable Trust Professor in Cancer Research.

Wistar will collaborate with Inovio Pharmaceuticals, Inc. (NASDAQ: INO) and Johns Hopkins Malaria Research Institute at the Johns Hopkins Bloomberg School of Public Health on this research effort.

Currently, RTS,S (Mosquirix™) is the only malaria vaccine that has moved through phase III trials, delivering modest protection for the populations most at risk. The vaccine also requires four doses and decreases in effectiveness over time providing partial protection. This issue of durability of protection as well as limited group protection supports the need to develop second generation vaccine candidates.

Incorporating Weiner’s and collaborators’ more than 25 years of research in design and delivery of synthetic DNA vaccines, the team’s goal is to generate a new vaccine that drives robust antigen-specific antibody and T cell immune responses. The Weiner Lab helped to found the field of nucleic acid vaccines and was the first to move DNA vaccines to clinical studies, establishing their safety and immunogenicity and opening up the field of DNA vaccines for clinical development.

“DNA vaccines have a significant public health potential to rapidly impact emerging pandemics, as this technology has conceptual safety, development, speed of production, field stability, and deliverability advantages for vaccine and immunotherapy development,” said Weiner. “These synthetic DNA approaches can be developed for important infectious diseases, and with our collaborators, we have shown this consistently by rapidly engineering multiple synthetic DNA vaccines and advancing them to clinical study with positive outcomes of safety and immune potency.”

Funding from the Bill & Melinda Gates Foundation will enable this team to adapt the technology to produce a synthetic DNA vaccine encoding antigens of Plasmodium (P.) faliciparum, the micro-organism that causes malaria. This strategy instructs the vaccine recipient to produce the antigen in his/her own body so that the immune system can be activated and mount a rapid and potent response against malaria. Fidel Zavala, M.D., professor in the Bloomberg School’s Department of Microbiology and Immunology and senior member of the Johns Hopkins Malaria Research Institute, will be responsible for testing the vaccine in animal models. Inovio Pharmaceuticals, Inc. will bring improved vaccine delivery and production know-how with their advanced CELLECTRA® electroporation delivery device that generates small, directional electric currents into the skin to facilitate optimal vaccine uptake, production of the antigen, and generation of relevant immune responses…


DCVMN – Developing Country Vaccine Manufacturers Network  [to 20 January 2018]
No new digest content identified.
IFPMA   [to 20 January 2018]
18 January 2018
Report shows life sciences industry alliance is taking action to curb antimicrobial resistance, with more to come
[See Reports/Research below for more detail]

Industry Watch   [to 20 January 2018]
:: Historic Deal Signed Between Panacea Biotec and Serum Institute of India
Jan 19, 2018, Panacea Biotec Ltd. (PBL), India’s leading biopharmaceutical company and among the largest manufacturer of vaccines, has signed two long-term collaboration agreements with Serum Institute of India Pvt. Ltd. (SII), world’s largest manufacturer of vaccines and SII’s wholly owned subsidiary, Bilthovan Biologicals B.V. (BBIO)…
Under the collaboration, SII is entitled to manufacture and sell fully liquid Whole cell Pertussis (wP) and Salk based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed and commercialized by PBL, a first-of-its-kind in this category…